Diagnosis and Allergen Identification of Perioperative Anaphylaxis

NCT06793163 | Recruiting

• 1 other identifier: 2024-620
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 5

Brief Summary

Perioperative anaphylaxis may lead to fatal respiratory and/or circulatory events, yet both clinical diagnosis and management are challenging. Serum tryptase is an indicator that can provide important retrospective diagnostic value for anaphylaxis. Another key point in perioperative anaphylaxis management is to identify the allergens, and thus avoid re-exposure during later perioperative management. Skin testing is an important way to identify allergens.

Conditions

Perioperative/Postoperative Complications; Anaphylaxis; Tryptase; Allergens; Skin Testing

Keywords

Perioperative/Postoperative Complications; Anaphylaxis; Tryptase; Allergens; Skin Testing

Outcome Measures

Primary Outcomes (1)

• Incidence of severe perioperative anaphylaxis

  Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. Severe perioperative anaphylaxis indicates grade 3 or above according to the World Allergy Organization systemic allergic reaction grading system. The incidence is calculated as the number of cases with severe perioperative anaphylaxis divided by the total number of cases who undergo surgery in the operating room during the study period.

  On the day of surgery in the operating room

Secondary Outcomes (3)

• Diagnostic rate of anaphylaxis in patients with suspected perioperative anaphylaxis.

  On the day of surgery in the operating room

• Incidence of perioperative anaphylaxis

  On the day of surgery in the operating room

• Allergen detection in patients with perioperative anaphlaxis

  At least 4-6 weeks after the confirmed perioperative anaphylaxis

Other Outcomes (3)

• Rate of surgical suspension due to suspected perioperative anaphylaxis.

  On the day of surgery suspected perioperative anaphylaxis

• Rate of unplanned ICU admission due to suspected perioperative anaphylaxis

  Within 24 hours of suspected perioperative anaphylaxis

• Rate of recurrence of perioperative anaphylaxis

  On the day of surgery in the operating room

Study Arms (1)

Suspected anaphylaxis

Adult patients with suspected anaphylaxis in the operating rooms, or with history of suspected anaphylaxis in the operating room.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspected anaphylaxis in the operating room.

You may qualify if:

• Aged 2 years or over;
• Suspected anaphylaxis in the operating rooms, or history of suspected anaphylaxis in the operating room.

You may not qualify if:

• Refuse to participate;
• Other conditions that are considered unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (5)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Beijing Anorectal Hospital (Beijing Erlong Road Hospital）

Beijing, Beijing Municipality, China

RECRUITING

Beijing Children's Hospital, Capital Medical University; National Center for Children's Health, China

Beijing, Beijing Municipality, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (3)

• Muraro A, Worm M, Alviani C, Cardona V, DunnGalvin A, Garvey LH, Riggioni C, de Silva D, Angier E, Arasi S, Bellou A, Beyer K, Bijlhout D, Bilo MB, Bindslev-Jensen C, Brockow K, Fernandez-Rivas M, Halken S, Jensen B, Khaleva E, Michaelis LJ, Oude Elberink HNG, Regent L, Sanchez A, Vlieg-Boerstra BJ, Roberts G; European Academy of Allergy and Clinical Immunology, Food Allergy, Anaphylaxis Guidelines Group. EAACI guidelines: Anaphylaxis (2021 update). Allergy. 2022 Feb;77(2):357-377. doi: 10.1111/all.15032. Epub 2021 Sep 1.

  PMID: 34343358 BACKGROUND

• Tran R, Pedersen K, Kolawole H, Roessler P, Scolaro R. Australian and New Zealand Anaesthetic Allergy Group/Australian and New Zealand College of Anaesthetists perioperative anaphylaxis management guideline 2022. Anaesth Intensive Care. 2024 May;52(3):147-158. doi: 10.1177/0310057X231215823. Epub 2024 Apr 8.

  PMID: 38587791 BACKGROUND

• Manian DV, Volcheck GW. Perioperative Anaphylaxis: Evaluation and Management. Clin Rev Allergy Immunol. 2022 Jun;62(3):383-399. doi: 10.1007/s12016-021-08874-1. Epub 2021 Jul 10.

  PMID: 34247332 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Postoperative Complications; Anaphylaxis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

86-10-83572784; wangdongxin@hotmail.com

Ya-Wei Li, MD

CONTACT

86-10-83572460; liyawei@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Department of Anesthesiology

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: January 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (5)